Ortho Development Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 50
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253161 | Balanced Knee System TriMax Porous Femoral Components | December 19, 2025 |
| K251052 | Trivicta® Hip Stem | May 22, 2025 |
| K242984 | BKS Revision System | October 25, 2024 |
| K242833 | Legend® Acetabular Shell | October 11, 2024 |
| K233758 | Trivicta Hip Stem | March 8, 2024 |
| K142146 | IBIS PEDICLE SCREW SYSTEM | December 11, 2014 |
| K141001 | ALPINE HIP STEM; ALPINE HA HIP STEM | July 30, 2014 |
| K132697 | ENCOMPASS 10/12 HIP STEM | June 20, 2014 |
| K133386 | OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM | March 11, 2014 |
| K133449 | KASM KNEE ARTICULATING SPACER MOLDS | February 18, 2014 |
| K131022 | OVATION 10/12 HIP STEM | October 16, 2013 |
| K131337 | BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA | October 11, 2013 |
| K131785 | PAGODA PEDICLE SCREW SYSTEM | August 20, 2013 |
| K122588 | VUSION CS PLUS | June 12, 2013 |
| K123457 | BALANCED KNEE SYSTEM HIGH FLEX PS | March 22, 2013 |
| K111965 | VUSION(R) OS | October 25, 2011 |
| K111936 | ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD | September 21, 2011 |
| K103837 | BALANCED KNEE SYSTEM REVISION OFFSET TIBIA | March 24, 2011 |
| K103384 | ESCALADE ACETABULAR CUP SYSTEM | March 16, 2011 |
| K090705 | BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT | October 9, 2009 |